Cardiovascular Procedure KitRecalls & reported problems across all models
Terumo Cardiovascular Systems Corporation · 227 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Cardiovascular Procedure Kit model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 92
- Deaths reported
- 2
- Injuries reported
- 6
- Recalls
- 2
We found 227 models of Cardiovascular Procedure Kit by Terumo Cardiovascular Systems Corporation in the FDA's device registry (GUDID). Together they are named in 92 adverse event reports in the FDA's MAUDE database, received between Jun 8, 2018 and Sep 23, 2026 — classified as 2 deaths, 6 injuries, 84 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (28 reports).
2 FDA recall records name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Cardiovascular Procedure Kit recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 20, 2024Class IIOpen, Classified
Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg, potential myocardial tissue damage potentially requiring surgical or medical/pharmacological intervention
Z-1401-2024 · Root cause: Process control · names 165 of these models · Recall details · FDA record ↗
- Feb 3, 2022Class IITerminated
Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.
Z-0949-2022 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported Cardiovascular Procedure Kit problems
Device problems
- Fluid/Blood Leak28
- Disconnection14
- Leak/Splash9
- Break7
- Crack7
- Device Misassembled During Manufacturing /Shipping6
- Connection Problem5
- Infusion or Flow Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions53
- Blood Loss28
- No Known Impact Or Consequence To Patient20
- No Consequences Or Impact To Patient11
- Insufficient Information4
- Hemolysis3
- Hemorrhage/Blood Loss/Bleeding2
- Death1
Cardiovascular Procedure Kit models
227 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- 1 recall5 reports
- 1 recall2 reports
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- 1 recall1 death1 report
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- Cardiovascular Procedure Kit 71064-01Laparoscope, General & Plastic Surgery1 recall0 reports
- 1 recall0 reports
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- Cardiovascular Procedure Kit 76498Laparoscope, General & Plastic Surgery1 recall0 reports
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Recent Cardiovascular Procedure Kit adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872965 ↗MalfunctionAug 5, 2026Leak/Splash
It was reported that during use of the device for cardiopulmonary bypass, there was a leak at a Y connector in cardioplegia pack within the neonate tubing pack. No other details regarding the nature of this event were provided.
Patient problems: Insufficient Information
MAUDE report 50148098 ↗MalfunctionJul 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25827876 ↗MalfunctionApr 24, 2026Material Deformation
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE ARTERIAL LINE HAD A TINY DIMPLE LOCATED IMMEDIATELY ADJACENT TO THE OXYGENATOR CONNECTION WHICH WAS CAUSING A DISRUPTION IN FORWARD FLOW. AS A RESULT, THE CENTRIFUGAL WAS CHANGED OUT DURING CPB. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS APPROXIMATELY A 3¿5-MINUTE DELAY. THERE WAS NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24984120 ↗MalfunctionMar 24, 2026Break
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE RED SUCKER TIP WAS DAMAGED; THE SURGEON HAD A SMALL PIECE. AS A RESULT, THERE WAS A 2-MINUTE DELAY IN CHANGING THE SUCKER OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO BLOOD LOSS NOR ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24680580 ↗MalfunctionMar 10, 2026Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE CARDIOPLEGIA TUBING CONFIGURATION WAS INCORRECT. AS A RESULT, THE TUBING WAS REPLACED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS BLOOD LOSS OF AN UNKNOWN AMOUNT. THERE WAS NO DELAY, NOR ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24562489 ↗MalfunctionFeb 17, 2026Fluid/Blood Leak
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THERE WAS A LEAK IN THE CENTRIFUGAL PUMP HEAD OUTLET DURING A PEDIATRIC CASE. AS MITIGATION, THE TEAM ADDED AN ADDITIONAL CLAMP, BUT THE LEAK PERSISTED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE A FEW MILLILITERS (ML) OF BLOOD LOSS, BASED ON A PHOTOGRAPH PROVIDED BY THE USER FACILITY, LIKELY LESS THAN 5ML. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24372412 ↗MalfunctionDec 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE VALVE IN THE PACK WAS LEAKING, FOUND AT THE END OF THE PROCEDURE. THERE WAS BLOOD LOSS OF APPROXIMATELY 10 MILLILITERS (ML) DURING A PEDIATRIC PROCEDURE. THERE WAS NO DELAY. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23783725 ↗MalfunctionNov 26, 2025Inaccurate Delivery; Device Misassembled During Manufacturing /Shipping; Inaccurate Delivery; Device Misassembled During Manufacturing /Shipping
PER CLINICAL REVIEW: THE ISSUE INVOLVED A TUBING PACK AND A CARDIOPLEGIA DELIVERY CIRCUIT WITHIN IT THAT HAD THE WRONG DIAMETER TUBING SIZE IN IT. THE TUBING SIZES WERE REVERSED. THE ISSUE WAS DISCOVERED DURING CARDIOPULMONARY BYPASS (CPB). THE CARDIOPLEGIA CIRCUIT TUBING WAS NOT CHANGED OUT. THERE WAS NO HARM TO THE PATIENT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE CARDIOPLEGIA CIRCUIT TUBING WAS NOT RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION, HOWEVER, PICTURES WERE TAKEN AND SHARED BY THE CUSTOMER CONFIRMING THE REPORTED ISSUE. FURTHER INVESTIGATION REVEALED THAT THE 1/4-INCH TUBING WAS USED WHERE THE 1/8-INCH TUBING SHOULD HAVE BEEN AND VICE VERSA. THE CARDIOPLEGIA TUBING CIRCUIT WAS ASSEMBLED IN A 1:4 RATIO INSTEAD OF A 4:1 RATIO. THIS WAS A WORKMANSHIP ERROR, WITH PRODUCTION ASSOCIATES NOT CORRECTLY USING THE SPECIFIED DIAMETER TUBING, IDENTIFIED IN THE CUSTOMERS' SPECIFICATIONS DIAGRAM. THE RESULT OF THIS INCORRECT ASSEMBLY IS THAT THE INCORRECT VOLUME AND CONCENTRATION OF CARDIOPLEGIA WAS DELIVERED TO THE PATIENT SINCE THE CUSTOMER WAS NOT AWARE OF THE TUBING DIAMETER CHANGE AND DID NOT CHANGE THE FLOW CONSTANT FACTOR ON THE ROLLER PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23662852 ↗MalfunctionNov 24, 2025Inaccurate Delivery; Device Misassembled During Manufacturing /Shipping; Inaccurate Delivery; Device Misassembled During Manufacturing /Shipping
PER CLINICAL REVIEW: THE TEAM EXPERIENCED AN ISSUE WITH THEIR TUBING PACK AND THE CARDIOPLEGIA DELIVERY CIRCUIT WITHIN IT THAT HAD THE WRONG DIAMETER TUBING SIZES IN IT. THE TUBING SIZES WERE REVERSED. THIS WAS DISCOVERED DURING CARDIOPULMONARY BYPASS (CPB). THE CARDIOPLEGIA CIRCUIT TUBING WAS NOT CHANGED OUT. THERE WAS NO HARM TO THE PATIENT, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE RESULT OF THIS INCORRECT ASSEMBLY WAS THAT THE INCORRECT VOLUME AND CONCENTRATION OF CARDIOPLEGIA WAS DELIVERED TO THE PATIENT. THIS OCCURRED BECAUSE THE CUSTOMER WAS NOT AWARE OF THE TUBING DIAMETER CHANGE AND DID NOT CHANGE THE FLOW CONSTANT FACTOR ON THE ROLLER PUMP. ALSO, THE CUSTOMER WAS MOST LIKELY USING A DELNIDO CARDIOPLEGIA MIXTURE, WHICH IS DICTATED TO BE DELIVERED IN A 1:4 RATIO, THAT IS 1 PART BLOOD TO 4 PARTS CRYSTALLOID. THE RESULT WAS THAT THE PATIENT HEART WAS DIFFICULT TO ARREST, AS THE IMPROPER CONCENTRATION OF BLOOD CARDIOPLEGIA WAS DELIVERED. THUS, THE PATIENT WAS UNDERDOSED BLOOD CARDIOPLEGIA. THE CARDIOPLEGIA CIRCUIT TUBING WAS NOT RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION, HOWEVER PICTURES WERE TAKEN AND SHARED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23639392 ↗MalfunctionOct 31, 2025Deformation Due to Compressive Stress; Pressure Problem; Deformation Due to Compressive Stress; Pressure Problem
PER CLINICAL REVIEW: THE COMPLAINT INVOLVED A TUBING PACK THAT WAS CONNECTED TO A PEDIATRIC OXYGENATOR THAT HAD A SEVERE KINK IN THE ARTERIAL TUBING LINE EXITING THE ARTERIAL PORT OF THE OXYGENATOR. THIS WAS DISCOVERED DURING INITIATION OF BYPASS. THEN THE OXYGENATION PERFORMANCE OF THE OXYGENATOR STARTED TO DECREASE, IMPACTING THE PARTIAL PRESSURE OF OXYGEN (PO2) VALUES TO DECLINE. BYPASS WAS INTERRUPTED TO CHANGE OUT THE OXYGENATOR AND TUBING PACK WITH A COMPLETE NEW SET. THERE WAS A DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED AND THERE WAS NO HARM TO THE PATIENT. THE OXYGENATOR AND TUBING PACK WERE NOT RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION. A DATA LOG REVIEW WAS NOT SHARED WITH THE MANUFACTURER. PICTURES WERE TAKEN OF THE KINKED TUBING BY THE CUSTOMER DURING BYPASS AND SHARED WITH THE MANUFACTURER CONFIRMING THE KINKED TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437866 ↗MalfunctionOct 31, 2025Crack; Leak/Splash; Pressure Problem; Crack; Leak/Splash; Pressure Problem
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE MALE CONNECTOR ON LINE 11 LEAKED DUE TO A CRACK IN THE CONNECTOR AND COULD NOT PROVIDE ENOUGH PRESSURE TO UTILIZE THE CARDIOPLEGIA LINE. AS MITIGATION, THE TEAM REPLACED THE LINE WITH AN EIGHT-FOOT PRESSURE LINE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437402 ↗MalfunctionOct 31, 2025Crack; Leak/Splash; Pressure Problem; Crack; Leak/Splash; Pressure Problem
PER CLINICAL REVIEW: THIS COMPLAINT INVOLVED A TUBING PACK THAT HAD A MALE CONNECTOR IN ONE OF THE ANCILLARY TUBING LINES LEAK BLOOD DURING CARDIOPULMONARY BYPASS. THE LINE AND CONNECTOR WERE CHANGED OUT WITH ANOTHER LINE/CONNECTOR AND THERE WAS NO HARM TO THE PATIENT. THE LINE AND CONNECTOR WERE NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION, AND NO PICTURES WERE TAKEN BY THE CUSTOMER AND SHARED. THIS COMPLAINT IS MOST LIKELY A WORKMANSHIP ISSUE WITH NOT ENOUGH SOLVENT BOND APPLICATION TO THE LINE AND CONNECTOR, BUT WITHOUT THE RETURN OF THE COMPLAINT DISPOSABLE, IT IS DIFFICULT TO GIVE A DEFINITIVE ROOT CAUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437356 ↗MalfunctionOct 28, 2025Crack; Leak/Splash; Pressure Problem; Crack; Leak/Splash; Pressure Problem
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE MALE CONNECTOR ON LINE 11 LEAKED DUE TO A CRACK IN THE CONNECTOR AND COULD NOT PROVIDE ENOUGH PRESSURE TO UTILIZE THE CARDIOPLEGIA LINE. AS MITIGATION, THE TEAM REPLACED THE LINE WITH AN EIGHT-FOOT PRESSURE LINE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23410390 ↗MalfunctionOct 28, 2025Component Misassembled; Component Misassembled
PER CLINICAL REVIEW: THIS COMPLAINT INVOLVED TUBING PACKS AND THE CARDIOPLEGIA DELIVERY TUBING WITHIN IT. THE CARDIOPLEGIA TUBING KITS WERE RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE FIRST ERROR WAS THAT ONE CARDIOPLEGIA DELIVERY TUBING CIRCUIT HAD THE INCORRECT TUBING DUROMETER IN IT. THE CARDIOPLEGIA CIRCUIT SHOULD HAVE BEEN ONE TUBING WITH 1/4 X 1/16, 68 DUROMETER MATED WITH ANOTHER TUBING 1/8 X 1/16. THE PACK WAS DISCOVERED WITH TUBING 1/4 X 1/16, 70 DUROMETER MATED WITH 1/8 X 1/16 TUBING. DUROMETER OF TUBING IS THE SOFTNESS OF THE TUBING AND TYPICALLY WILL NOT AFFECT THE VOLUME OF CARDIOPLEGIA DELIVERED TO THE PATIENT. IT MAY HAVE MINIMAL AFFECT TO THE CLINICIANS' ABILITY TO LOAD THE TUBING. THE SECOND ERROR WAS THAT ONE CARDIOPLEGIA DELIVERY TUBING CIRCUIT HAD THE INCORRECT WALL THICKNESS IN IT. THE CARDIOPLEGIA CIRCUIT SHOULD HAVE BEEN ONE TUBING WITH 1/4 X 1/16 THICKNESS MATED WITH ANOTHER TUBING 1/8 X 1/16 THICKNESS. THE PACK WAS DISCOVERED WITH TUBING 1/4 X 3/32 THICKNESS MATED WITH 1/8 X 1/16 THICKNESS. THE TWO VARYING THICKNESS OF TUBING WOULD MOST LIKELY AFFECT THE REQUIRED OPTIMAL OCCLUSION SETTING OF THE ROLLER PUMP. BOTH OF THESE TUBINGS ARE DOUBLE LOADED I
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23410015 ↗
Other Terumo Cardiovascular Systems Corporation products
- Terumo Advanced Perfusion System 131 models · 1,869 reports · 11 recalls
- Capiox RX Hollow Fiber Oxygenator with Hardshell Reservoir6 models · 99 reports · 1 recall
- CDI Blood Parameter Monitoring System 5502 models · 75 reports
- CDI OneView Monitoring System3 models · 6 reports · 1 recall
- Sarns Cardioplegia Set3 models · 0 reports · 1 recall
- CDI Blood Parameter Monitoring System 5002 models · 39 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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